CABA-201 for Lupus
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called CABA-201 for individuals with active systemic lupus erythematosus (SLE), an autoimmune disease where the immune system attacks healthy tissue. The trial evaluates the safety and effectiveness of this treatment, particularly for those with lupus nephritis (a type of kidney inflammation caused by lupus) or moderate to severe SLE that doesn't affect the kidneys. Participants must have a confirmed lupus diagnosis and experience symptoms that impact daily life, such as frequent flare-ups or kidney issues. As a Phase 1, Phase 2 trial, this research aims to understand how the treatment works in people and measure its effectiveness in an initial, smaller group, offering participants a chance to be among the first to benefit from this innovative therapy.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.
Is there any evidence suggesting that CABA-201 is likely to be safe for humans?
Research has shown that the treatment CABA-201 was safe in earlier studies. Most patients did not experience cytokine release syndrome (CRS) or neurotoxicity (ICANS), which are possible side effects. Specifically, only three out of eight patients had mild CRS. Overall, CABA-201 was well-tolerated by patients. These findings suggest that the treatment may offer a good balance between benefits and risks for people with lupus.12345
Why do researchers think this study treatment might be promising for lupus?
Researchers are excited about CABA-201 for lupus because it offers a novel approach compared to existing treatments. Unlike standard treatments, which often include immunosuppressants and corticosteroids that can have significant side effects, CABA-201 is engineered to target the immune system more precisely. This treatment involves an infusion with preconditioning, which might lead to better control of lupus symptoms with potentially fewer side effects. By focusing on specific immune pathways, CABA-201 could provide a more effective and safer option for patients, especially those with lupus nephritis (LN) and non-renal systemic lupus erythematosus (SLE).
What evidence suggests that CABA-201 might be an effective treatment for lupus?
Research has shown that CABA-201, the investigational treatment under study in this trial, holds promise for treating lupus. In an earlier study, three out of four lupus patients experienced significant symptom improvement or remission. Importantly, most patients did not encounter serious side effects, such as cytokine release syndrome, a potentially dangerous immune reaction. Early findings suggest that CABA-201 could be a safe and effective option for people with lupus. Overall, these initial results offer encouragement for those considering CABA-201 as a treatment.12367
Who Is on the Research Team?
Medical Director
Principal Investigator
Cabaletta Bio
Are You a Good Fit for This Trial?
Adults aged 18-65 with active Systemic Lupus Erythematosus (SLE) can join. For lupus nephritis, a biopsy must confirm it. Participants need positive tests for specific antibodies and have moderate to severe SLE symptoms if not renal-related. Exclusions include other kidney diseases, previous CAR T cell therapy, reactions to certain drugs, ongoing serious infections or organ transplants.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Preconditioning
Participants receive a standard regimen including cyclophosphamide (CY) and fludarabine (FLU) before the infusion of CABA-201
Treatment
Participants receive a single dose of CABA-201
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- CABA-201
CABA-201 is already approved in United States for the following indications:
- None approved; under investigation for systemic lupus erythematosus, myositis, systemic sclerosis, myasthenia gravis, and pemphigus vulgaris
Find a Clinic Near You
Who Is Running the Clinical Trial?
Cabaletta Bio
Lead Sponsor